OPIS s.r.l.
Medical Writer
OPIS s.r.l., Chicago, Illinois, United States, 60290
The Medical Writer reports to the Head of Medical Writing and is responsible for drafting and editing preclinical/clinical documents such as study protocols, study reports, patient information and informed consent forms, and other medical and regulatory documents (including Investigators’ Brochure, IMPD, etc.), abstracts, manuscripts, slide and poster presentations. He/she carries out medical writing activities interfacing with other stakeholders and works in compliance with applicable procedures, requirements, and timelines.
In order to make an application, simply read through the following job description and make sure to attach relevant documents.Role and General Responsibilities:
Carries out work within the scope of his/her activities by collaborating with the Direct Manager to define priorities and manage routine activities. Contributes to the management and development of procedures related to the activities in which he/she is involved and ensures that the outputs of activities meet the quality standards required by the company. Ensures the timely compilation of activity tracking and attendance systems. Ensures, in carrying out the tasks entrusted, compliance with rules, regulations, and agreements regarding confidentiality and privacy, promptly reporting deviations.
Duties and Specific Tasks:
Draw up, edit, and review preclinical/clinical documents such as clinical study reports, study protocols, patient information and informed consent forms, and other medical and regulatory documents.Develop scientific manuscripts and abstracts reporting clinical study results, as well as slide and poster presentations.Prepare regulatory and preclinical/clinical documents for drug development and registration activities.Liaise with Biometrics staff, Pharmacovigilance, and Clinical Operations Units for information or guidance, as necessary.Manage documents to produce submission-ready content for customers.Perform literature searches and reviews as necessary to obtain background information for the development of documents.Work in accordance with Regulations, Good Clinical Practices, ICH guidelines, and Company Standard Operating Procedures.Create and maintain an audit trail of all document changes.Ensure the quality and accuracy of documents in English.Participate in meetings as required.Ensure correct archiving of files and documents, as per procedure.Enter all the information required in the TRACK system on an ongoing basis.Other duties as assigned.Work & Education Minimum Requirements:
Master’s degree in biomedical/scientific disciplines.Knowledge of medical concepts and terminology.Good knowledge of the ICH-GCP guidelines and the methodology of clinical research.Fluent in English; specific knowledge of biomedical English is required.Planning and organizational skills.Communication skills.Team-working oriented.Who we are:Founded in 1998 in Italy and now operating at an international level, OPIS is a full-service science-driven biotech focused CRO providing premium trial management for multi-country clinical trials, including state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of current projects.OPIS added value lies in its highly specialized professionals who can assist their clients using their deep know-how and experience to guarantee a top-quality level of Clinical Trial Management and ability to operate in a wide range of fields (medical writing, scientific and statistical consultancy for trial design, regulatory activities, pharmacovigilance, etc.) always contributing to our clients’ challenging achievements.
What we offer:
We offer a competitive salary with other benefits/bonuses and opportunity to develop your professional career with an expanding and growing company.Please read the information notice on the processing of personal data in the candidates information section of our company website.Candidate Privacy Policy
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In order to make an application, simply read through the following job description and make sure to attach relevant documents.Role and General Responsibilities:
Carries out work within the scope of his/her activities by collaborating with the Direct Manager to define priorities and manage routine activities. Contributes to the management and development of procedures related to the activities in which he/she is involved and ensures that the outputs of activities meet the quality standards required by the company. Ensures the timely compilation of activity tracking and attendance systems. Ensures, in carrying out the tasks entrusted, compliance with rules, regulations, and agreements regarding confidentiality and privacy, promptly reporting deviations.
Duties and Specific Tasks:
Draw up, edit, and review preclinical/clinical documents such as clinical study reports, study protocols, patient information and informed consent forms, and other medical and regulatory documents.Develop scientific manuscripts and abstracts reporting clinical study results, as well as slide and poster presentations.Prepare regulatory and preclinical/clinical documents for drug development and registration activities.Liaise with Biometrics staff, Pharmacovigilance, and Clinical Operations Units for information or guidance, as necessary.Manage documents to produce submission-ready content for customers.Perform literature searches and reviews as necessary to obtain background information for the development of documents.Work in accordance with Regulations, Good Clinical Practices, ICH guidelines, and Company Standard Operating Procedures.Create and maintain an audit trail of all document changes.Ensure the quality and accuracy of documents in English.Participate in meetings as required.Ensure correct archiving of files and documents, as per procedure.Enter all the information required in the TRACK system on an ongoing basis.Other duties as assigned.Work & Education Minimum Requirements:
Master’s degree in biomedical/scientific disciplines.Knowledge of medical concepts and terminology.Good knowledge of the ICH-GCP guidelines and the methodology of clinical research.Fluent in English; specific knowledge of biomedical English is required.Planning and organizational skills.Communication skills.Team-working oriented.Who we are:Founded in 1998 in Italy and now operating at an international level, OPIS is a full-service science-driven biotech focused CRO providing premium trial management for multi-country clinical trials, including state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of current projects.OPIS added value lies in its highly specialized professionals who can assist their clients using their deep know-how and experience to guarantee a top-quality level of Clinical Trial Management and ability to operate in a wide range of fields (medical writing, scientific and statistical consultancy for trial design, regulatory activities, pharmacovigilance, etc.) always contributing to our clients’ challenging achievements.
What we offer:
We offer a competitive salary with other benefits/bonuses and opportunity to develop your professional career with an expanding and growing company.Please read the information notice on the processing of personal data in the candidates information section of our company website.Candidate Privacy Policy
#J-18808-Ljbffr